title: Intravitreal Aflibercept Injection for Macular Edema Resulting from Central Retinal Vein Occlusion: One-Year Results of the Phase 3 GALILEO Study.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of intravitreal aflibercept injections for treatment of macular edema secondary to central retinal vein occlusion (CRVO).
  
  
  METHODS
  A randomized, multicenter, double-masked phase 3 study.
  
  
  METHODS
  A total of 177 treatment-naive patients with macular edema secondary to CRVO were randomized in a 3:2 ratio.
  
  
  METHODS
  Patients received either 2-mg intravitreal aflibercept or sham injections every 4 weeks for 20 weeks. From week 24 to 48, the aflibercept group received aflibercept as needed (pro re nata [PRN]), and the sham group continued receiving sham injections.
  
  
  METHODS
  The primary efficacy end point was the proportion of patients who gained 15 letters or more in best-corrected visual acuity (BCVA) at week 24. This study reports week 52 results including the proportion of patients who gained 15 letters or more in BCVA and the mean change from baseline BCVA and central retinal thickness. Efficacy end points at week 52 were all exploratory.
  
  
  RESULTS
  At week 52, the mean percentage of patients gaining 15 letters or more was 60.2% in the aflibercept group and 32.4% in the sham group (P = 0.0004). Aflibercept patients, compared with sham patients, had a significantly higher mean improvement in BCVA (+16.9 letters vs. +3.8 letters, respectively) and reduction in central retinal thickness (-423.5 μm vs. -219.3 μm, respectively) at week 52 (P < 0.0001 for both). Aflibercept patients received a mean of 2.5 injections (standard deviation, 1.7 injections) during PRN dosing. The most common ocular adverse events in the aflibercept group were related to the injection procedure or the underlying disease, and included macular edema (33.7%), increased intraocular pressure (17.3%), and eye pain (14.4%).
  
  
  CONCLUSIONS
  Treatment with intravitreal aflibercept provided significant functional and anatomic benefits after 52 weeks as compared with sham. The improvements achieved after 6 monthly doses at week 24 largely were maintained until week 52 with as-needed dosing. Intravitreal aflibercept generally was well tolerated.
authors.affiliation: Service d'ophtalmologie, Hopital Pellegrin, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; Université Bordeaux Segalen, Bordeaux, France; INSERM, L'Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED), Centre INSERM U897-Epidemiologie-Biostatistique, Bordeaux, France. Electronic address: jean-francois.korobelnik@chu-bordeaux.fr.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Korobelnik
authors.affiliation: Department of Ophthalmology, University of Bonn, Bonn, Germany.
authors.forename: Frank G
authors.initials: FG
authors.lastname: Holz
authors.affiliation: Department of Ophthalmology, University of Kiel, Kiel, Germany.
authors.forename: Johann
authors.initials: J
authors.lastname: Roider
authors.affiliation: Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Science, Nagoya, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Ogura
authors.affiliation: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
authors.forename: Christian
authors.initials: C
authors.lastname: Simader
authors.affiliation: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
authors.forename: Ursula
authors.initials: U
authors.lastname: Schmidt-Erfurth
authors.affiliation: Department of Ophthalmology, University Medical Center, Johannes Gutenberg-Universität Mainz, Mainz, Germany.
authors.forename: Katrin
authors.initials: K
authors.lastname: Lorenz
authors.affiliation: Department of Ophthalmology, Juntendo University Urayasu Hospital, Chiba, Japan.
authors.forename: Miki
authors.initials: M
authors.lastname: Honda
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Robert
authors.initials: R
authors.lastname: Vitti
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Alyson J
authors.initials: AJ
authors.lastname: Berliner
authors.affiliation: Bayer HealthCare AG, Berlin, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Hiemeyer
authors.affiliation: Bayer HealthCare AG, Berlin, Germany; Department of Neurology, University of Erlangen-Nürnberg, Germany.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Stemper
authors.affiliation: Bayer HealthCare AG, Berlin, Germany; Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Zeitz
authors.affiliation: Bayer HealthCare AG, Berlin, Germany; Department of Neurology, Heinrich-Heine-Universität, Düsseldorf, Germany.
authors.forename: Rupert
authors.initials: R
authors.lastname: Sandbrink
mesh_terms: D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology; D011788:Quality of Life; D040262:Receptors, Vascular Endothelial Growth Factor / Q000009:adverse effects / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D012170:Retinal Vein Occlusion / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor